MedImmune Says It's Answered FDA's FluMist Queries

The biotech hopes to have the vaccine approved in time for the coming flu season.

MedImmune ( MEDI) said Monday evening that it has submitted responses to questions from the Food and Drug Administration regarding FluMist, its experimental flu vaccine.

The FDA issued a "complete response letter" regarding FluMist on July 10, which asked for additional information before the regulatory agency could render a decision on the vaccine's approval. At the time, MedImmune said it would take between 30 and 45 days to respond to the FDA query.

MedImmune would like the FDA to approve FluMist by the beginning of November, which would give the company just enough time to start selling the vaccine, given as a nasal mist, for the upcoming 2002-2003 flu season. However, most analysts, and even MedImmune executives, acknowledge that this timeline is a long shot .

If FluMist is not ready until next year's flu season, MedImmune said it would be forced to reduce 2002 earnings guidance by 25 cents, to 27 cents per share. The company is now forecasting pro forma earnings of 62 cents to 67 cents per share this year, or a net loss of $4.22 to $4.27 per share as calculated by generally accepted accounting principles. This estimate assumes FluMist approval in 2002.